Gayatri R. Rao, MD, JD
VP, Regulatory Policy and Patient Advocacy
Gayatri Rao is Vice President for Regulatory Policy and Patient Advocacy at Rocket Pharma. Gayatri most recently served as Director of the Office of Orphan Products Development (OOPD) within the US Food and Drug Administration (FDA), where she was responsible for implementing statutory programs focused on promoting the development of medical products for rare diseases. At the FDA, Gayatri served as the FDA’s rare disease lead for interactions with Congress, international and national regulatory organizations, industry sponsors and patient advocacy groups. During her tenure, she oversaw a dramatic rise in the number of orphan drug designation requests, granted over 2000 designations, and issued over 250 orphan exclusivity decisions. In addition, she worked to successfully implement the Rare Pediatric Disease Priority Review Voucher program and launched a $2M Orphan Product Natural History Grant Program to complement the office’s longstanding $15M Orphan Product Clinical Trial Grant Program and $6M Pediatric Device Consortia Grant Program.
Prior to heading FDA’s OOPD, Gayatri was an Associate Chief Counsel in the FDA’s Office of Chief Counsel and began her career at an international law firm in Washington, D.C., where she focused on healthcare and food and drug law related matters. She holds a JD from the University of Pennsylvania Law School, a Master of Bioethics from the University of Pennsylvania School of Medicine, and an MD from Rutgers New Jersey Medical School.Back to Management